Sterile filtration ensures that everything entering the bioreactor meets requirements to optimize cell culture or fermentation growth. Incorporating prefiltration into this process will protect the life of the sterilizing filters and lower your overall filtration costs. Product solutions are discussed below.
Filtration is a vital component in assuring efficient operation and maximum output of chromatography systems in purification processes. Contaminants to be removed can include endotoxins - charged particles that can prematurely consume resin capacity - and organic or inorganic particles in base solutions, buffer solutions and cleaning solutions used to regenerate the columns between batches. Removing these contaminants optimizes column performance and keeps them operating at the highest level.
Sterile filtration of biologics is a preferred method due to the product's heat sensitivity. To avoid degradation and loss of product during final fill CPF's application engineers work with you to:
Sterilizing insurance. Our PPS Filters are recommended for the most stringent and critical applications to insure 100% bacteria retention. This filter’s media consists of two identical, hydrophilic membranes. Pore sizes range from 0.03 to 1.2 µm.
Targeted bacteria retention. DPPS filters deliver custom bacteria retention based on your fluids load. You choose the pore sizes of both the prefilter and final layer to achieve targeted results. The prefilter acts as both a bioburden reduction and particle removing filter.
Sterilizing fluids with high particle loads. CPF’s HPPS Filters handle increased capacity and high particle loads with an integrated prefilter for particle removal and a sterilizing final filter. This dual layer model reduces multiple filtrations into a single step.
Sterilizing & endotoxin removal. The PPC Filter consists of a double layer sterilizing membrane for stringent bacteria retention and it has been positively charged to remove any gram-negative bacteria debris.
Bioburden reduction, non-sterilizing. BPS Filters reduce microbials in aqueous liquids when sterilizing is not required. These hydrophilic filters are available in single and dual layer configurations with a choice of pore sizes for each layer to provide the right level of retention.
Mycoplasma control. When your goal is mycoplasma reduction, all CPF sterilizing filters rated at 0.10 micron will reliably reduce mycoplasma in your fluids. When a validation of >log 7 removal is required, choose any CPF sterilizing filter rated at 0.03 micron.
Protecting tank contents and the environment. CPF's PTR Filters are hydrophobic sterilizing filters made with Polytetrafluoroethylene (PTFE) membrane to capture microbials as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators and the environment in the surrounding work space.
Clarifying and prefiltering microbials and particulates found in APIs, raw ingredients, cell culture media, buffers and excipients will reduce the contamination load on the final filter. In processing applications where sterile product is critical and final filters carry the greatest cost, CPF prefilters do the bulk of filtration, resulting in:
High particle loads. BCWPS Filters, made from CPF's proprietary high capacity PES membrane, excel in protecting downstream filters. With its low binding characteristics, BCWPS filters are used for the clarification and prefiltration of products with high proteins and preservatives. Membrane prefilters, such as the BCWPS offer greater retention than a depth filter.
High flow and particle removal. Our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity while still delivering high flow rates.
Fine particles in water, solvents and chemicals. PPD Prefilters, constructed with pleated polypropylene depth media, are versatile filters offering broad chemical compatibility and high retention of fine particles in a variety of fluids used in pharmaceutical applications.
Heavy solids content and contamination. CPF's HLP Prefilters, constructed with high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.
Endotoxin removal. CPF's GPC Filter is a standalone endotoxin removal filter used for the filtration of aqueous fluids that contain negatively charged biological contaminants, such as endotoxin, virus and other cell fragments.
Critical Process Filtration will test your process stream on our product to ensure filter performance.
Sterilizing and Bioburden Reduction Filtration in Biopharmaceutical Processes
Filtration of Raw Materials, Intermediates, APIs and Excipients
in Small Molecule & Biological Pharmaceuticals
Critical Process Filtration filters are designed for use in cGMP compliant processes. Our state-of-the-art manufacturing facility and quality-management system both meet ISO 9001:2015 standards. Each operation from assembly and test to cleaning, drying, and packaging is done in appropriately rated clean rooms, and each filter is assigned a lot code to ensure the traceability of manufacturing data and materials. A sophisticated MRP system collects and processes real-time data from manufacturing centers and inspection points.
The materials used to construct pharmaceutical-grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. Critical Process Filtration filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber-releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical-grade filters are below current USP limits as specified for water for injection.